Clinical Research Associate I

SmartRecruiters, Inc.; Madrid; A distancia; EUR 45.000 - 60.000; Jornada completa

Descripción de la vacante

AbbVie is seeking a Clinical Research Monitor to oversee activities at investigative sites for Phase 1-4 trials, ensuring protocol adherence and regulatory compliance. The role emphasizes data integrity, safety reporting, and readiness for regulatory inspections.

The ideal candidate has at least 1 year of clinically-related experience, preferably 6 months in monitoring or as a Study Coordinator, and a health-related qualification; Clinical Trials Master’s degree is preferred.

Formación

• Appropriate tertiary qualification in health-related field; Clinical Trials Master’s Degree preferred.
• Minimum 1 year of clinically-related experience; 6 months preferred in monitoring or as Study Coordinator.
• Experience with on-site monitoring of investigational trials and knowledge of regulatory requirements.

Responsabilidades

• Monitors activities at clinical investigative sites to ensure protocol execution and compliance.
• Ensures adherence to GCPs, ICH Guidelines, SOPs and monitoring plans.
• Overviews site personnel activities and ensures action plans for compliance; ensures regulatory inspection readiness.
• Ensures data quality and timely reporting of safety events by site personnel.
• Trains site personnel on protocol and regulatory requirements with project team input.
• Manages investigator payments and negotiates site agreements; completes expense reports.
• Identifies potential investigators/sites to support planned studies.

Conocimientos

Clinical monitoring

Site management

Data quality assurance

Regulatory knowledge

Planning & organization

Communication

Educación

Clinical Trials Master’s Degree

Descripción del empleo

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

• Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
• Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
• Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.
• Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
• Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines.
• Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.

Qualifications

• Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred with Clinical Trails Master´s Degree.
• Minimum of1 year of clinically-related experience, of which a period of6 months is preferable in independent clinical research monitoring or experience as a Study CoordinatorExperience in on-site monitoring of investigational drug or device trials is required.
• Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
• Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function.
• Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment.

Remote based in madrid

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.